Reducing Risk of Dementia through De-prescribing (R2D2)

通过取消处方降低痴呆症风险 (R2D2)

• 批准号: 10392349
• 负责人: Noll L. Campbell
• 金额: $ 64.27万
• 依托单位: PURDUE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392349
• 关键词: Acute; Adverse event; Age; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American; Anti-Cholinergics; Anxiety; Awareness; Brain; Caring; Cessation of life; Characteristics; Cholinergic Receptors; Clinical; Cluster randomized trial; Cognition; Cognitive; Complement; Delirium; Dementia; Disease; Educational Intervention; Elderly; Enrollment; Epidemiology; Exposure to; Gender; Genetic; Geriatrics; Health; Health Care Costs; Healthcare Systems; Hospitalization; Human; Impaired cognition; Information Systems; Institute of Medicine (U.S.); Intervention; Measurement; Measures; Memory; Mental Depression; Modeling; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Outcome; Pain; Participant; Pathology; Patient Care; Patient Monitoring; Patient Outcomes Assessments; Patient Self-Report; Pharmaceutical Preparations; Pharmacists; Physicians; Population; Prevalence; Primary Health Care; Protocols documentation; Quality of life; Race; Randomized; Randomized Controlled Trials; Risk; Safety; Screening procedure; Severity of illness; Sleeplessness; Societies; Target Populations; Testing; Time; United States Centers for Medicare and Medicaid Services; United States National Institutes of Health; Work; aging population; apolipoprotein E-4; base; care costs; cognitive testing; comorbidity; dementia risk; design; disability; executive function; experience; follow-up; group intervention; health care service utilization; health record; high risk; improved; indexing; information processing; medical specialties; mortality; mouse model; non-demented; patient safety; primary care setting; primary outcome; processing speed; randomized trial; response; risk minimization; safety outcomes; treatment as usual

PROJECT SUMMARY/ABSTRACT Both the American Geriatrics Society and the Center for Medicare and Medicaid Services have identified anticholinergics as inappropriate medications in older adults due to their adverse cognitive effects causing an increased risk of Alzheimer's disease and related dementias (ADRD). Every year, as many as 30% of older Americans use at least one of these medications, and more than 50% use at least one strong anticholinergic in five years. Despite awareness of these adverse cognitive effects, there has been no decline in prevalence over the last two decades. Several studies have identified higher risks of ADRD among users of these medications, however it is unknown whether stopping these medications in current users results in acute and sustained improvements in cognition. We propose a new trial called “Reducing Risk of Dementia through De-prescribing (R2D2)” to determine the efficacy of a pharmacist-driven de-prescribing protocol to improve cognition among primary care older adults currently using an anticholinergic medication. We will focus the intervention on primary care patients at high risk of cognitive decline due to current cognitive complaints or those making at least one error on a cognitive screening tool, while excluding those with dementia. The design will be a cluster randomized trial, randomizing physicians to minimize risk of contamination. Participants will be randomized to usual care (UC) or an active intervention group (ACT) that will receive a pharmacist-based de-prescribing intervention modeled after our prior work. The R2D2 study will enroll 344 older adults to determine the impact of the intervention on cognition at 6, 12, 18, and 24 months after baseline. The trial will monitor the safety of the intervention on depression, anxiety, pain, insomnia, and quality of life. We hypothesize that the ACT group will have better scores on cognitive assessments, no change in safety measures, and improvement in quality of life scores compared to usual care. If our hypothesis holds, this study would prove that the adverse cognitive effects of anticholinergics are reversible in older adults at high risk of ADRD, providing support for further work testing time to cognitive decline or dementia as a primary outcome. Interventions delaying the onset of cognitive impairment and dementia will have a significant impact on both the quality and costs of care of the aging population.

项目概要/摘要 美国老年医学会和医疗保险和医疗补助服务中心都已确定 抗胆碱能药物对老年人来说是不合适的药物，因为它们会产生不良的认知影响，导致 阿尔茨海默病和相关痴呆症 (ADRD) 的风险增加。每年有多达 30% 的老年人 美国人至少使用其中一种药物，并且超过 50% 的人至少使用一种强效抗胆碱能药物 五年。尽管人们意识到这些不利的认知影响，但患病率并没有下降 过去二十年。多项研究已发现这些药物使用者患 ADRD 的风险较高， 然而，目前尚不清楚当前使用者停止使用这些药物是否会导致急性和持续性的 认知能力的提高。 我们提出了一项名为“通过取消处方降低痴呆症风险 (R2D2)”的新试验，以确定 药剂师驱动的取消处方方案对改善初级保健老年人认知的功效 目前正在使用抗胆碱能药物。我们将把干预重点放在高初级保健患者身上 由于当前的认知抱怨或在认知上至少犯了一个错误而导致认知能力下降的风险 筛查工具，同时排除痴呆症患者。该设计将是一项整群随机试验，随机化 医生尽量减少污染风险。参与者将被随机分配到常规护理 (UC) 或积极治疗 干预组（ACT）将接受基于药剂师的取消处方干预，该干预以我们的模型为基础 之前的工作。 R2D2 研究将招募 344 名老年人来确定干预措施对认知的影响 基线后 6、12、18 和 24 个月。该试验将监测抑郁症干预措施的安全性， 焦虑、疼痛、失眠和生活质量。我们假设 ACT 组在以下方面会有更好的分数 与相比，认知评估、安全措施没有变化以及生活质量评分有所改善 平时的护理。 如果我们的假设成立，这项研究将证明抗胆碱能药物的不良认知作用是 对于ADRD高风险老年人来说是可逆的，为进一步的工作测试时间提供认知认知支持 衰退或痴呆作为主要结局。延缓认知障碍发生的干预措施和 痴呆症将对老年人口的护理质量和费用产生重大影响。